Effect of Awake Prone Positioning on Endotracheal Intubation in Patients With COVID-19 and Acute Respiratory Failure
Authors: Waleed Alhazzani, Ken Kuljit S. Parhar, Jason Weatherald, Zainab Al Duhailib, Mohammed Alshahrani, Abdulrahman Al-Fares, Sarah Buabbas, Sujith V. Cherian, Laveena Munshi, Eddy Fan, Fahad Al-Hameed, Jamal Chalabi, Amera A. Rahmatullah, Erick Duan, Jennifer L. Y. Tsang, Kimberley Lewis, François Lauzier, John Centofanti, Bram Rochwerg, Sarah Culgin, Katlynne Nelson, Sheryl Ann Abdukahil, Kirsten M. Fiest, Henry T. Stelfox, Haytham Tlayjeh, Maureen O. Meade, Dan Perri, Kevin Solverson, Daniel J. Niven, Rachel Lim, Morten Hylander Møller, Emilie Belley-Cote, Lehana Thabane, Hani Tamim, Deborah J. Cook, Yaseen M. Arabi, Kara Nerenberg, Alexis Turgeon, Charles Francoeur, Guillaume Leblanc, Maude St-Onge, Lorenzo Del Sorbo, Rosa M Estrada-Y-Martin, Hala Hamada, Abdulaziz Al-Mutawa , Ardeshir Algooneh, Farhan Alenezi, Eman Al Qasim, Hussain Al Haji, Mohammad Al Mutairi, Omar Zumai, Amal Matroud, Musharaf Sadat, Felwa Bin Humaid, Wedyan Al Wehaibi, Faisal Al-Basseet, Mohammed Alobaidi, Muhammed Alshahrani, Yousef Almubarak, Laila Perlas Asonto, Charlene Mapusao, Katherine Cruz, Arivu Muthu, Shaya Y AlQahtani, Mae Ann Santillan, Amera Rahmatullah, Shatha Baraja’a, Haya Al Othaimeen, Fahad Al-Hameed, Gulam Rasool, Ohoud Alorabi, Gauhar Khan, Jamal Chalabi, Zuheb Nagoor, Ammar Alkroud, Arwa Alhussaini, Ahmad Qureshi, Ahmad Quadri, Babar Javed, Khalid Idrees
Journal: JAMA (2022)

The efficacy and safety of prone positioning is unclear in nonintubated patients with acute hypoxemia and COVID-19.To evaluate the efficacy and adverse events of prone positioning in nonintubated adult patients with acute hypoxemia and COVID-19.Pragmatic, unblinded randomized clinical trial conducted at 21 hospitals in Canada, Kuwait, Saudi Arabia, and the US. Eligible adult patients with COVID-19 were not intubated and required oxygen (≥40%) or noninvasive ventilation. A total of 400 patients were enrolled between May 19, 2020, and May 18, 2021, and final follow-up was completed in July 2021.Patients were randomized to awake prone positioning (n = 205) or usual care without prone positioning (control; n = 195).The primary outcome was endotracheal intubation within 30 days of randomization. The secondary outcomes included mortality at 60 days, days free from invasive mechanical ventilation or noninvasive ventilation at 30 days, days free from the intensive care unit or hospital at 60 days, adverse events, and serious adverse events.Among the 400 patients who were randomized (mean age, 57.6 years [SD, 12.83 years]; 117 [29.3%] were women), all (100%) completed the trial. In the first 4 days after randomization, the median duration of prone positioning was 4.8 h/d (IQR, 1.8 to 8.0 h/d) in the awake prone positioning group vs 0 h/d (IQR, 0 to 0 h/d) in the control group. By day 30, 70 of 205 patients (34.1%) in the prone positioning group were intubated vs 79 of 195 patients (40.5%) in the control group (hazard ratio, 0.81 [95% CI, 0.59 to 1.12], P = .20; absolute difference, -6.37% [95% CI, -15.83% to 3.10%]). Prone positioning did not significantly reduce mortality at 60 days (hazard ratio, 0.93 [95% CI, 0.62 to 1.40], P = .54; absolute difference, -1.15% [95% CI, -9.40% to 7.10%]) and had no significant effect on days free from invasive mechanical ventilation or noninvasive ventilation at 30 days or on days free from the intensive care unit or hospital at 60 days. There were no serious adverse events in either group. In the awake prone positioning group, 21 patients (10%) experienced adverse events and the most frequently reported were musculoskeletal pain or discomfort from prone positioning (13 of 205 patients [6.34%]) and desaturation (2 of 205 patients [0.98%]). There were no reported adverse events in the control group.In patients with acute hypoxemic respiratory failure from COVID-19, prone positioning, compared with usual care without prone positioning, did not significantly reduce endotracheal intubation at 30 days. However, the effect size for the primary study outcome was imprecise and does not exclude a clinically important benefit.ClinicalTrials.gov Identifier: NCT04350723.